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AML New Drug | FLT3 Inhibitor Gefitinib: Price and Review Report in China – Moshang Pharma

2026年第6周02.02-02.08全球创新药研发概览 摩熵医药 2026-02-10 2026年第6周02.02-02.08国内医药大健康行业政策法规汇总 摩熵医药 2026-02-10 基于代谢酶和转运体的体外药物相互作用研究概述与案例分析 单晓蕾, 付淑军, 高广花, 孙涛, 王庆利, 余珊珊 国家药品监督管理局药品审评中心 2019-11-01 C…

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Global Innovative Drug R&D Overview (Week 6, 2026, February 2-8) – Moshang Pharmaceuticals (February 10, 2026) Summary of Domestic Pharmaceutical and Healthcare Industry Policies and Regulations (Week 6, 2026, February 2-8) – Moshang Pharmaceuticals (February 10, 2026) Overview and Case Analysis of In Vitro Drug Interaction Studies Based on Metabolic Enzymes and Transporters – Shan Xiaolei, Fu Shujun, Gao Guanghua, Sun Tao, Wang Qingli, Yu Shanshan – Center for Drug Evaluation, National Medical Products Administration (November 1, 2019) Top 10 Global CRO Companies in 2021 – Pharmaceutical Insights (February 26, 2022) Market Insight Center: Pharmaceutical Market Sales Data Analysis, Intelligent Insight, Competitive Landscape Monitoring Acute Myeloid Leukemia (AML) is a highly heterogeneous group of malignant hematologic malignancies. The occurrence and progression of AML are associated with numerous gene mutations, such as FLT3, NPM1, CEBPA, TP53, etc.

Among these, the FLT3 gene is particularly important, as it is the most common gene mutation in AML (FLT3 gene mutation is the most common genetic alteration and poor prognostic factor in acute myeloid leukemia (AML), present in approximately 25-30% of AML patients). Patients with FLT3-mutant AML generally have poor survival. On January 30, 2021, Astellas’ new drug Xospata® (gilteritinib fumarate tablets) was approved by the National Medical Products Administration (NMPA) of China for the treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations (conditional approval).

Gefitinib received priority review status from the China National Medical Products Administration (NMPA) in July 2020 and was included in the third batch of urgently needed overseas new drugs in November 2020; it took less than 10 months from the submission of its New Drug Application (NDA) in China to its approval. This product was originally jointly developed by Kotobuki Pharmaceuticals and Astellas. Recently, the 2021 edition of the Chinese Society of Hematologic Malignancies (CSCO) guidelines was updated, and novel small-molecule targeted drugs, including FLT3 inhibitors, have brought hope to the treatment of AML patients.

In May 2021, the FLT3 inhibitor gidatetinib was included in the 2021 CSCO guidelines for the treatment of relapsed or refractory AML (non-APL). Analysis of domestic innovative drug/improved new drug clinical trial applications/approval for clinical trials/applications for marketing authorization/approval for marketing authorization. A review of the list of innovative drugs approved by the US FDA in the first half of 2026! Domestic companies BeiGene and Hisun Pharmaceutical are on the list!

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Sino Biopharmaceutical’s TQC3721 goes global with AstraZeneca, breaking the monopoly of oncology drugs going global. Moshang attends AIBC 2026 | BCPM’s biopharmaceutical data solutions empower the implementation of AI in the pharmaceutical industry. Sino Biopharmaceutical makes a major move: licensing its COPD drug TQC3721 to AstraZeneca for $1.9 billion, and simultaneously securing exclusive rights to two major respiratory drugs from GSK. Overview of global innovative drug R&D (Week 27, 2026, June 29 – July 5). Summary of domestic pharmaceutical and healthcare industry policies and regulations (Week 27, 2026, June 29 – July 5). Analysis of domestic generic drug/biosimilar application/approval data (Week 27, 2026, June 29 – July 5). Analysis of domestic innovative drug/improved new drug clinical trial application/approval/marketing application/marketing approval data (Week 27, 2026, June 29 – July 5). Moxhang Consulting Pharmaceutical Industry Observation Weekly Report (June 29, 2026 – July 5, 2026) July 5, 2026: 28 pages Analysis of the Differences in Business Models between Innovative Drug CROs and Medical Device CROs July 1, 2026: 13 pages June 2026 Global Monthly Report on New Drugs in Development June 30, 2026: 40 pages June 2026 Moxhang Pharmaceutical and Healthcare Investment & Financing & Transaction Monthly Report June 30, 2026: 20 pages June Pharmaceutical Market Hot Topics Review 12411 July 7, 2026: 19:30 2028 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) Overseas February 17, 2028: 02:198143 2028 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) Overseas 2028.01.06 01.08 7522 2027 American Society of Clinical Oncology (ASCO) Annual Meeting (Overseas) 2027.06.04 06.08 7553 Good News | Henlius Biotech’s 4 Core Products Included in the 2026 National Essential Medicines List, Continuously Improving Accessibility of High-Quality Biologics 2026-07-10 Authoritative Certification, Moving Forward with Honors | Panlong Qi Tablets Selected for the “National Essential Medicines List (2026 Edition)” 2026-07-10 Although the CRL Issuance is Temporarily Suspended, the FDA is Eliminating “Concerns” 2026-07-10 June 2026 Moshang Pharmaceutical and Healthcare Investment & Financing & Transaction Monthly Report Moshang Consulting 20 2 The Era of Pediatric Drugs:Insights into the Blue Ocean of Innovative Drugs and Project Approval Opportunities Under Policy Breakthroughs (Moshang Consulting) 13 11 Announcement Regarding Drugs and Related Information Passing the Preliminary Formal Review of the 2026 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog and Commercial Insurance Innovative Drug Catalog Issuing Authority: National Healthcare Security Administration 2026-06-29 Notice on Publicly Soliciting Opinions Issuing Authority: Center for Drug Evaluation (CDE) 2026-06-25

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